PRRC Service

According to EU 2017/745 MDR Article 15, PRRC, which is required by medical device manufacturers, can be an outsourced service for micro and small businesses.

“Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organization but shall have such person permanently and continuously at their disposal.”

We offer PRRC service for your business to have a sustainable knowledge base. We also carry out Vigilance and Post Market Surveillance activities within this service.